2025-522498-12-00招募中4 期
A low-intervention randomised, double-blind, placebo-controlled pilot trial evaluating the feasibility, tolerability and adherence of alternate-day oral Duroferon (ferrous sulphate) in adolescent girls with iron deficiency, and the diagnostic performance of the IRON-5 screening tool (IRONGIRLS-PILOT).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- 1. Feasibility, including recruitment, retention, adherence and tolerability. 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).
研究概览
简要总结
- To evaluate the feasibility of Duroferon 100 mg administered on alternate days in combination with Iron Smart, compared with placebo plus Iron Smart, in adolescent girls with iron deficiency.
- To evaluate the diagnostic performance of IRON-5 in identifying iron deficiency (ferritin <15 µg/L).
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Student at Polhemskolan, Lund
- •Age ≥15 years
- •Post-menarcheal
- •Written informed consent from the participant
- •Written informed consent from legal guardian(s) if <18 years
- •Serum ferritin <30 µg/L
排除标准
- •Chronic inflammatory disease (e.g. rheumatoid arthritis, Crohn’s disease)
- •Ongoing acute infection (e.g. tonsillitis, urinary tract infection)
- •CRP >10 mg/L
- •Current iron supplementation (except multivitamins)
- •Anaemia (Hb <110 g/L if <18 years; <117 g/L if ≥18 years, according to regional reference limits)
- •Iron overload (serum ferritin >150 µg/L; WHO definition)
- •Clinically significant vitamin B12 deficiency requiring immediate medical evaluation or treatment (e.g. serum vitamin B12 <150 pmol/L).
- •Use of medication known to interfere with iron absorption or cause clinically significant interaction with oral iron (e.g. fluoroquinolones, tetracyclines, bisphosphonates, levodopa, methyldopa, aluminium- or magnesium-containing antacids), defined as regular or daily use (≥3 times per week).
研究组 & 干预措施
Duroferon depottabletter
Test
干预措施: Duroferon depottabletter (Drug)
Duroferon placebo
Placebo
干预措施: Duroferon placebo (Drug)
结局指标
主要结局
1. Feasibility, including recruitment, retention, adherence and tolerability. 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).
1. Feasibility, including recruitment, retention, adherence and tolerability. 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).
次要结局
- Change in ferritin concentration.
- Change in haemoglobin, TSAT, vitamin B12 and 25-hydroxyvitamin D from screening to follow-up.
- Associations between iron deficiency and selected factors (dietary patterns, BMI, menstrual characteristics including bleeding volume, menstrual pain and analgesic use, hormonal contraceptive use, physical activity, socioeconomic status and country of birth).
- Associations between fatigue and self-rated QoL and factors other than iron deficiency (e.g. vitamin B12 and vitamin D deficiency, anxiety/depression and lifestyle factors).
研究者
Clinical trial team
Scientific
Region Skane
研究点 (1)
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